Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000156684
Ethics application status
Approved
Date submitted
3/02/2014
Date registered
10/02/2014
Date last updated
6/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of a survivorship care plan in breast cancer
Scientific title
A single-arm study of survivors of early breast cancer receiving standard follow-up care supplemented by a written survivorship care plan- quality of life and care coordination outcomes
Secondary ID [1] 284024 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 291068 0
Quality of life 291069 0
Unmet needs 291070 0
Condition category
Condition code
Cancer 291412 291412 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Survivorship care plan- A patient-held written plan for follow-up care after treatment for early breast cancer.
The survivorship care plan has three components:
(1) Record of cancer pathology and treatment
(2) Plan for follow-up care (specialist visits and tests)
(3) Lifestyle information to maximise health and wellbeing

The care plan will be developed by one of the patient's regular cancer specialists, in consultation with the woman herself, during a 30 minute consultation. A schedule for follow-up consultations and tests will be developed. The woman will also be advised about what to expect (health and emotions) in the months and years to follow, and who to contact if there are problems between visits.
Intervention code [1] 288715 0
Other interventions
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291405 0
Feasibility of survivorship care plan use in follow-up care

Measured by
(1) Ongoing use of care plan during consultations
and
(2) Survivorship Care Plan Feedback Questionnaire for Participants (SCPFQ-P)

These are measurement tools (written questionnaires) developed for this study.
Timepoint [1] 291405 0
18 months
Secondary outcome [1] 306687 0
Unmet needs

Measured by
Cancer Survivors’ Unmet Needs measure (CaSUN)- validated written questionnaire
Timepoint [1] 306687 0
6 months
Secondary outcome [2] 306688 0
Satisfaction with care and satisfaction with care coordination

Measured by
(1) Satisfaction with care coordination questionnaire (SCCQ) and
(2) Patient Satisfaction Scale (PSS)

These are measurement tools (written questionnaires) used in previous research in cancer survivors.
Timepoint [2] 306688 0
6 months
Secondary outcome [3] 306689 0
Quality of life

Measured by
Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES)- This is a tool that combines the FACT-B (breast) with an additional questions relating to endocrine symptoms. (Validated written questionnaire.)
Timepoint [3] 306689 0
6 months
Secondary outcome [4] 306690 0
Satisfaction with care and satisfaction with care coordination

Measured by
(1) Satisfaction with care coordination questionnaire (SCCQ) and
(2) Patient Satisfaction Scale (PSS)

These are measurement tools (written questionnaires) used in previous research in cancer survivors.
Timepoint [4] 306690 0
18 months
Secondary outcome [5] 306730 0
Unmet needs

Measured by
Cancer Survivors’ Unmet Needs measure (CaSUN)- validated written questionnaire
Timepoint [5] 306730 0
18 months
Secondary outcome [6] 306731 0
Quality of life

Measured by
Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES)- This is a tool that combines the FACT-B (breast) with an additional questions relating to endocrine symptoms. (Validated written questionnaire.)
Timepoint [6] 306731 0
18 months

Eligibility
Key inclusion criteria
Women treated for early invasive breast cancer, completed hospital-based treatment (surgery, radiotherapy and/or chemotherapy)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Advanced breast cancer at diagnosis
Treatment not yet completed
Poor English causing difficulty with completion of questionnaires

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a single arm trial; all participants receive the intervention (the survivorship care plan)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of results of quality of life, satisfaction and unmet needs questionnaires.
Comparison of outcomes between age groups, cancer treatment and time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2010
Actual
5/10/2010
Date of last participant enrolment
Anticipated
28/10/2011
Actual
28/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2042 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 7732 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 288653 0
Charities/Societies/Foundations
Name [1] 288653 0
Friends of the Mater Foundation
Country [1] 288653 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
City Rd
Darlington NSW 2008
Country
Australia
Secondary sponsor category [1] 287364 0
None
Name [1] 287364 0
Address [1] 287364 0
Country [1] 287364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290502 0
St Vincents Mater Health Human Research Ethics Committee
Ethics committee address [1] 290502 0
c/o Research Office
Level 6, deLacy Building
St Vincent’s Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 290502 0
Australia
Date submitted for ethics approval [1] 290502 0
17/02/2010
Approval date [1] 290502 0
11/03/2010
Ethics approval number [1] 290502 0
10/033
Ethics committee name [2] 290503 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [2] 290503 0
Human Ethics
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [2] 290503 0
Australia
Date submitted for ethics approval [2] 290503 0
31/08/2010
Approval date [2] 290503 0
21/09/2010
Ethics approval number [2] 290503 0
13189

Summary
Brief summary
This study will evaluate whether the addition of a survivorship care plan to standard follow-up care is feasible and whether it will have an impact on quality of life and unmet needs in survivors of early breast cancer.

Who is it for?
Participants in this study are women aged 18 years and above who have completed hospital-based treatment for early invasive breast cancer (surgery, radiotherapy and/or chemotherapy).

Study details
All participants in this study receive a survivorship care plan in addition to standard follow-up care. The survivorship care plan is a written summary of cancer treatment with a follow-up plan for future care. The care plan will be developed by one of the patient's regular cancer specialists, in consultation with the woman herself. A schedule for follow-up consultations and tests will be developed. The woman will also be advised about what to expect (health and emotions) in the months and years to follow, and who to contact if there are problems between visits.

Participants will complete baseline questionnaires evaluating their unmet needs and quality of life. They will then receive routine cancer follow-up, supplemented by the survivorship care plan for a period of 18 months. Questionnaires will be repeated at 6 and 18 months from enrolment in the study. The 6 and 18 months questionnaires will also include an evaluation of the care plan.
Trial website
None
Trial related presentations / publications
None to date
Public notes

Contacts
Principal investigator
Name 45990 0
Dr Meagan Brennan
Address 45990 0
The Poche Centre
40 Rocklands Rd
North Sydney
NSW 2060
Country 45990 0
Australia
Phone 45990 0
61 2 9911 7250
Fax 45990 0
Email 45990 0
[email protected]
Contact person for public queries
Name 45991 0
Meagan Brennan
Address 45991 0
The Poche Centre
40 Rocklands Rd
North Sydney
NSW 2060
Country 45991 0
Australia
Phone 45991 0
61 2 9911 7250
Fax 45991 0
Email 45991 0
[email protected]
Contact person for scientific queries
Name 45992 0
Meagan Brennan
Address 45992 0
The Poche Centre
40 Rocklands Rd
North Sydney
NSW 2060
Country 45992 0
Australia
Phone 45992 0
61 2 9911 7250
Fax 45992 0
Email 45992 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.